Effect of CREON on Exocrine Pancreatic Insufficiency (EPI... | NCT04949828

Studies
Effect of CREON on Exocrine Pancreatic Insufficiency (EPI) Symptoms

NCT04949828

Sponsor

AbbVie

Status

Completed

Last Update Posted

Mar 28, 2024Actual

Enrollment

63Actual

Phase

Not provided

Conditions

Chronic Pancreatitis

Interventions

CREON

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 16, 2021Actual

Primary Completion Date

Feb 29, 2024Actual

Completion Date

Feb 29, 2024Actual

First Submitted Date

Jun 21, 2021

First Submission Date that Met QC Criteria

Jul 1, 2021

First Posted Date

Jul 2, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2024

Last Update Posted Date

Mar 28, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Exocrine Pancreatic Insufficiency (EPI) is a condition where pancreatic enzyme quantity or activity is reduced below threshold needed for normal digestion. Symptoms include bloating, flatulence, diarrhea and steatorrhea. This is an observational study assessing for effect of CREON on symptoms of EPI in participants with EPI due to chronic pancreatitis.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

63Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Participants on CREON			Drug: CREON

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CREON	Drug	Oral Capsules	Participants on CREON	pancrelipase

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Score of EPI Symptoms Domain Using an EPI Patient-Reported Outcomes Questionnaire		Up to 1 month

Secondary Outcomes

Measure	Description	Time Frame
Change in T-scores for Patient-Reported Outcomes Measurement and Information System(PROMIS) Questionnaires for Anxiety, Depression, and Fatigue		Up to 1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Medical history of chronic pancreatitis (CP).
Diagnosis of Exocrine Pancreatic Insufficiency (EPI).

Exclusion Criteria:

--History of cystic fibrosis, pancreatic cancer, pancreatic surgery, gastric bypass surgery, extensive bowel surgery, inflammatory bowel disease, celiac disease, irritable bowel syndrome

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult participants with medical diagnosis of chronic pancreatitis (CP) and exocrine pancreatic insufficiency (EPI)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ABBVIE INC.	AbbVie	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University School of Med /ID# 229530		Stanford	California	94305-2200	United States
University of Florida - Archer /ID# 227057

Label	URL
Related info	View source

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D050500	Pancreatitis, Chronic
D010188	Exocrine Pancreatic Insufficiency

Ancestor Terms

ID	Term
D010195	Pancreatitis
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020799	Pancrelipase

Ancestor Terms

ID	Term
D008049	Lipase
D002265	Carboxylic Ester Hydrolases
D004950	Esterases
D006867	Hydrolases

Browse Leaves

Not provided

Browse Branches

Not provided